Format Questions

Understanding the CyberIRB Format

Are this program and the server behind it Title 21 CFR 11 compliant?

Title 21, Part 11 of the Food and Drug Administration (FDA) Code of Federal Regulations establishes guidelines for managing documents that relate to electronic records and electronic signatures. The FDA’s biggest concern pertaining to Cyber was to ensure that the electronic signature is performed by the person signing the document.

This consideration is why we require the principal investigator (PI) to sign documents using their unique username and password. Each PI should have received their own unique ID and password. These tools verify the PI’s identity and permissions for a particular document. By requiring users to follow these steps, we ensure Title 21 CFR 11 compliance throughout the lifespan of an electronic submission.

Process Questions

FAQs About the Submission Process & CyberIRB

Do I need to use CyberIRB now? When will paper no longer be accepted?

We encourage you to become proficient on Cyber now. Our system eventually will become fully electronic, and paper submissions will no longer be accepted.

What if my PI takes too long to submit?

The PI is ultimately responsible for the content of each item submitted for IRB approval. It is up to you, the submitter, to develop a system with your investigator(s) to ensure that they have reviewed what is being submitted to our IRB. Our IRB does not have control over PI review. The IRB review process will not begin until the signature from the PI has been obtained.

Can I make modifications to studies that were originally approved outside of Cyber?

Yes. For any study that has already received IRB approval, you can submit:

Modifications

Significant new findings

Violations

Continuing reviews

Cyber contains all IRB-approved studies. If you do not see a particular study listed that should be available to you, please contact Angela Carpenter.

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